RxBNNeupogen
filgrastim
2 reference · 7 biosimilar-only
Reference Product
Neupogen
filgrastim
351(a) Reference Product (Approval Date 28-Jun-2000)
ApplicantAmgen Inc.
BLA103353
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Neupogen
filgrastim
351(a) Reference Product (Approval Date 28-Jun-2000)
ApplicantAmgen Inc.
BLA103353
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Neupogen
filgrastim
351(a) Reference Product (Approval Date 20-Feb-1991)
ApplicantAmgen Inc.
BLA103353
RouteIntravenous, Subcutaneous
Presentation
Single-Dose Vial
Neupogen
filgrastim
351(a) Reference Product (Approval Date 20-Feb-1991)
ApplicantAmgen Inc.
BLA103353
·RouteIntravenous, Subcutaneous
Presentation
Single-Dose Vial
Interchangeable Biosimilars
No interchangeable biosimilars in this group.
Biosimilars (not interchangeable)
Filkri
filgrastim-laha
351(k) Biosimilar (Approval Date 15-Jan-2026)
ApplicantAccord BioPharma Inc.
BLA761027
RouteIntravenous, Subcutaneous
Presentation
Pre-Filled Syringe
Filkri
filgrastim-laha
351(k) Biosimilar (Approval Date 15-Jan-2026)
ApplicantAccord BioPharma Inc.
BLA761027
·RouteIntravenous, Subcutaneous
Presentation
Pre-Filled Syringe
Nivestym
filgrastim-aafi
351(k) Biosimilar (Approval Date 20-Jul-2018)
ApplicantHospira Inc., a Pfizer Company
BLA761080
RouteIntravenous, Subcutaneous
Presentation
Single-Dose Vial
Nivestym
filgrastim-aafi
351(k) Biosimilar (Approval Date 20-Jul-2018)
ApplicantHospira Inc., a Pfizer Company
BLA761080
·RouteIntravenous, Subcutaneous
Presentation
Single-Dose Vial
Nivestym
filgrastim-aafi
351(k) Biosimilar (Approval Date 20-Jul-2018)
ApplicantHospira Inc., a Pfizer Company
BLA761080
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Nivestym
filgrastim-aafi
351(k) Biosimilar (Approval Date 20-Jul-2018)
ApplicantHospira Inc., a Pfizer Company
BLA761080
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Nypozi
filgrastim-txid
351(k) Biosimilar (Approval Date 28-Jun-2024)
ApplicantTanvex BioPharma USA, Inc.
BLA761126
RouteIntravenous, Subcutaneous
Presentation
Pre-Filled Syringe
Nypozi
filgrastim-txid
351(k) Biosimilar (Approval Date 28-Jun-2024)
ApplicantTanvex BioPharma USA, Inc.
BLA761126
·RouteIntravenous, Subcutaneous
Presentation
Pre-Filled Syringe
Releuko
filgrastim-ayow
351(k) Biosimilar (Approval Date 25-Feb-2022)
ApplicantKashiv BioSciences, LLC
BLA761082
RouteIntravenous, Subcutaneous
Presentation
Single-Dose Vial
Releuko
filgrastim-ayow
351(k) Biosimilar (Approval Date 25-Feb-2022)
ApplicantKashiv BioSciences, LLC
BLA761082
·RouteIntravenous, Subcutaneous
Presentation
Single-Dose Vial
Releuko
filgrastim-ayow
351(k) Biosimilar (Approval Date 25-Feb-2022)
ApplicantKashiv BioSciences, LLC
BLA761082
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Releuko
filgrastim-ayow
351(k) Biosimilar (Approval Date 25-Feb-2022)
ApplicantKashiv BioSciences, LLC
BLA761082
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Zarxio
filgrastim-sndz
351(k) Biosimilar (Approval Date 6-Mar-2015)
ApplicantSandoz Inc.
BLA125553
RouteIntravenous, Subcutaneous
Presentation
Pre-Filled Syringe
Zarxio
filgrastim-sndz
351(k) Biosimilar (Approval Date 6-Mar-2015)
ApplicantSandoz Inc.
BLA125553
·RouteIntravenous, Subcutaneous
Presentation
Pre-Filled Syringe